The Effect of Macronutrients on Fibroblast Growth Factor 21 (FGF21) Secretion
30 de marzo de 2022 actualizado por: University of Copenhagen
The aim of this randomized cross-over study is to investigate how consumption of protein and fat affects the FGF21 response triggered by sucrose. The hypothesis is that the consumption of protein, but not fat, will attenuate the FGF21 response triggered by sucrose.
Exploratory, and in order to investigate mechanisms behind the potential attenuation in the sucrose-induced FGF21 response after protein consumption, glucose, insulin, glucagon, triglycerides, amino acids, glicentin and cholecystokinin (CCK) will be assessed before and after consumption of sucrose, sucrose+protein and sucrose+fat. Furthermore, the association between the FGF21 response after consumption of sucrose, sucrose + protein and sucrose + fat and subjective rating of appetite for sweet will also be investigated.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Frederiksberg, Dinamarca, 1958
- Department of Nutrition, Exercise and sports, University of Copenhagen
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 50 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Informed consent
- Caucasian
- Healthy men and women
- Age between 18-50 years
- Body mass index (BMI) between 20-27 kg/m2
Exclusion Criteria:
- Chronic diseases or significant health problems that are disruptive for participation in the study (as judged by the principal investigator/clinical responsible)
- Use, currently or within the previous 3 months, of medication that has the potential of affecting any of the blood parameters assessed in the study (as judged by the principal investigator/clinical responsible)
- Blood donation within the last 3 months or during the study period
- Smoking, smoking cessation within the past 3 months, or nicotine use (electronic cigarettes, gum, etc.)
- Currently dieting or having lost/gained a significant amount of weight (±3 kg) in the previous 3 months
- Women who are pregnant, breast-feeding or have the intention of becoming pregnant during the study period
- Food allergies or food intolerance relevant for the study
- Substance abuse (within the last 12 months)
- Alcohol intake above the recommendations from the Danish Health and Medicines Authority
- Simultaneous participation in other clinical studies that can interfere with the current study
- Inability, physically or mentally, to comply with the procedures required by the study protocol
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Sucrose
The participants will be served a test drink with 75g sucrose dissolved in water
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The participants consume A) water with 75 g sucrose
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Experimental: Sucrose + protein
The participants will be served a test drink with 75g sucrose dissolved in water and ~ 100 kcal protein (whey protein)
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The participants consume B) water with 75 g sucrose + approx.
100 kcal protein
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Experimental: Sucrose + fat
The participants will be served a test drink with 75g sucrose dissolved in water and ~ 100 kcal fat (cream)
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The participants C) water with 75 g sucrose + approx.
100 kcal fat
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difference in FGF21 concentration after consumption of sucrose vs. sucrose+protein
Periodo de tiempo: Difference in plasma concentration of FGF21 between two test days
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Difference (pg/ml) in plasma FGF21 concentration after consumption of sucrose vs. sucrose+protein.
Concentration of FGF21 is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma concentration of FGF21 between two test days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difference in FGF21 concentration after consumption of sucrose vs. sucrose+fat
Periodo de tiempo: Difference in plasma concentration of FGF21 between two test days
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Difference (pg/ml) in plasma FGF21 concentration after consumption of sucrose vs. sucrose+fat.
FGF21 is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma concentration of FGF21 between two test days
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Difference in glucose concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Periodo de tiempo: Difference in plasma concentration of glucose between the three test days
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Difference (mmol/l) in plasma glucose concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Glucose is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma concentration of glucose between the three test days
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Difference in insulin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Periodo de tiempo: Difference in serum concentration of insulin between the three test days
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Difference (pmol/l) in serum insulin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Insulin is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in serum concentration of insulin between the three test days
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Difference in glucagon concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Periodo de tiempo: Difference in plasma concentration of glucagon between the three test days
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Difference (pg/ml) in plasma glucagon concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Glucagon is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma concentration of glucagon between the three test days
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Difference in triglyceride concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Periodo de tiempo: Difference in serum concentration of triglycerides between the three test days
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Difference (mmol/l) in serum triglyceride concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Triglyceride is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in serum concentration of triglycerides between the three test days
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Difference in amino acid concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Periodo de tiempo: Difference in serum concentration of amino acids between the three test days
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Difference in serum amino acid concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Amino acids are measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in serum concentration of amino acids between the three test days
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Difference in glicentin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Periodo de tiempo: Difference in plasma glicentin between the three test days
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Difference (pmol/l) in plasma glicentin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Glicentin is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma glicentin between the three test days
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Difference in CCK concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Periodo de tiempo: Difference in plasma CCK between the three test days
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Difference (pmol/l) in plasma CCK concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
CCK is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma CCK between the three test days
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Difference in appetite for sweet after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Periodo de tiempo: Difference in appetite for sweet between the three test days
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Difference in appetite for sweet is measured using visual analog scales (VAS).
The VAS consists of a 100 mm horizontal unbroken line with words anchored at each end describing the extremes.
The participants respond to the question asked by placing a vertical mark through the horizontal line corresponding to their perceived feeling at that particular time.
Appetite for sweet is assessed at time 0 and 30, 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in appetite for sweet between the three test days
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Matthew P Gillum, Novo Nordisk Foundation Center for Basic Metabolic Research, Health and Medical Sciences, University of Copenhagen
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
28 de septiembre de 2021
Finalización primaria (Actual)
23 de febrero de 2022
Finalización del estudio (Actual)
23 de febrero de 2022
Fechas de registro del estudio
Enviado por primera vez
9 de septiembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
27 de septiembre de 2021
Publicado por primera vez (Actual)
29 de septiembre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de marzo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
30 de marzo de 2022
Última verificación
1 de septiembre de 2021
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- The FGF21-macro study
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .